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Massive study tracks blood sugar in 2,179 pregnant women to uncover diabetes clues

NCT ID NCT04860336

Knowledge-focused Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed over 2,000 pregnant women to measure their blood sugar levels throughout pregnancy. The goal was to see how glucose patterns relate to gestational diabetes and whether the baby is born larger than normal. Researchers used continuous glucose monitors and standard tests to gather detailed information.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,179 people

The number who actually took part.

Started

Apr 2021

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant adults who enroll prior to 10w0d-14w0d gestation.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Maternal age \>=18 at consent * Singleton gestation * 10w0d-14w0d gestation at the time of the Visit 1 OGTT and CGM placement according to study dating criteria * Conceived using own oocyte * Willing and able to wear CGM as directed and adhere to CGM instructions * Planning to deliver at GO MOMs-affiliated hospital (see list of accrual sites in the protocol section "Key Roles and Contact Information"). Exclusion Criteria: * Pre-existing diabetes at enrollment * Currently self-monitoring blood glucose * Current use of medication with glycemic effects * Fetal malformation evident at or before enrollment that is likely lethal. This includes, but is not limited to, malformations such as anencephaly, hydrops, diffuse subcutaneous edema or cystic hygroma, ectopic cordis, and encephalocele * Known fetal aneuploidy based on chorionic villus sampling * Participation in other research study that may modify glycemic profile or study outcomes * History of bariatric surgery * Extensive skin changes or diseases making CGM sensor use problematic * Significant allergy to adhesive * Previous participation in GO MOMs * Current bulimia or anorexia nervosa * Overnight shift work that alters the sleep/wake periods * Hemoglobin A1c \>= 6.5%, fasting glucose \>= 126 mg/dL or 2 hr glucose \>= 200 mg/dL noted during OGTT at 10w0d-14w0d gestation * Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the site investigator

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Conditions

The condition(s) this trial relates to.

gestational diabetes pregnancy disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gestational diabetes Pregnancy related

Contacts and locations

Locations

  • Columbia University

    New York, New York, 10032, United States

  • Kaiser Permanente - Hawaii

    Honolulu, Hawaii, 96817, United States

  • Kaiser Permanente - Northwest

    Portland, Oregon, 97227, United States

  • Magee Womens Research Institute & Foundation

    Pittsburgh, Pennsylvania, 15213, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.